MMJ Bioscience Files Request with FDA to Open Phase 2 Study of Medical Cannabis in Progressive MS
MMJ Bioscience, which specializes in medical cannabis products, has filed a request with the U.S. Food and Drug Administration (FDA) to open Phase 2 clinical trials evaluating the company’s THC/CBD pharmaceutical compounds as possible treatments for symptoms of multiple sclerosis (MS).
THC refers to the tetrahydrocannabinol compound, part of the cannabis plant. CBD stands for cannabidiol, the compound that is thought to have the most healing potential.
“Our goal is to conduct clinical research and generate safety and efficacy data on our medication to support a comprehensive review by the FDA and approval as a prescription medicine that will deliver consistency and quality for multiple sclerosis patients,” Timothy Moynahan, chairman of MMJ, said in a press release.
Bianca Weinstock-Guttman, executive director of the New York State Multiple Sclerosis Consortium, is set to lead a study exploring the potential therapeutic applications of medical cannabis in patients with progressive MS with the goal of developing a prescription medicine. Weinstock-Guttman was hired by the company specifically to be the trial’s lead investigator.
This will be MMJ’s first trial of potential cannabis-based medicines for patients with MS and associated forms of pain and spasticity.
“[D]espite the growing acceptance of cannabis at the state level around the country, it really has no bearing on our strategy. The FDA will assess our new drug application based only on our scientific data, irrespective of the drug being sourced from natural botanical materials,” Moynahan added.
The FDA’s includes a section on cannabis-related questions, where readers can find more about THC and CBD, the potential benefits of cannabis-based products for certain patient communities, and the agency’s approach toward approving these products as treatments.
Early, preclinical studies report that medical cannabis is able to reduce MS-related neuropathic pain, and a literature review found certain cannabinoids may be able to reduce spasticity symptoms in MS patients. More research, including clinical trials in people, are needed to confirm these findings, the report noted.
MMJ Bioscience became the first company to obtain a Canadian license to produce medical cannabis in March, with the initial authorization covering products for MS and Huntington’s disease. The Health Canada license allows the company to extract cannabinoids from plants it grows to produce medicines for testing in clinical studies.